If your company has ever received a warning letter from the U.S. Food and Drug Administration (FDA), you know how serious they can be. It’s a shot across the bow, serving as notice of problems but also providing an opportunity to improve before more serious issues occur.

With that in mind, let’s look at the top issues that lead to warning letters, and what companies can do to avoid finding themselves in the same boat.

The number of networked medical devices is expected to grow 500% over the next decade, putting Internet of Things (IoT) front and center for life science companies looking to tap into this growing market.

In this post, we’ll look at what IoT means for pharmaceutical and medical device manufacturers, including new applications, emerging risks and the expertise companies will need to be successful.

This week’s roundup brings you the latest from the Life Sciences industry.

First, we see some big data developments for healthcare from the University of Chicago Medicine. Then, read up on the FDA’s efforts to reduce preventable adverse drug events. Finally, the Traqpath blog gives insight into managing Life Science compliance requirements in one central location for optimal results.

Risk has always been essential to ensuring quality in pharmaceutical and medical device manufacturing. But with the latest version of ISO 9001, risk is now officially part of the management system standard.

One of the biggest changes in ISO 9001:2015 is the replacement of preventive action with risk-based thinking requirements in context, leadership and planning sections.

Experts will say risk-based thinking is a watered-down version of more robust risk management processes, but the guiding principles are the same. Identify your hazards, consider the potential consequences and take action as necessary.

With that in mind, let’s look at 3 critical areas life sciences companies can integrate risk to improve quality and safety.

Pharmaceutical and medical device manufacturing is all about managing risk. How do you take a product from concept or molecule to finished product in a way that minimizes risks to patients and the company?

Organizations tend to focus on a standard set of risk tools, relying on things like Failure Modes and Effects Analysis (FMEA), risk matrices and the Risk Register to ensure risks are caught before they become problems.

And while these tools are incredibly valuable to risk management in general, sometimes it’s the process or system itself that creates hidden risks.

In today’s post, we’ll look at 4 of these risks, and how companies can address them.

After the mega-merger era of 2015-2016, the passage of the 21st Century Cures Act and a new administration in the White House, many in the medical device industry are wondering what changes are on the horizon for 2017.

It’s unclear whether the U.S. Food and Drug Administration (FDA) or the market will be the biggest driver of change, or exactly how these elements will affect the industry.

In this post, we’ll look at some of the most important medical device trends to watch this year.

The U.S. Food and Drug Administration (FDA) requires companies to validate any software used in design, manufacture, packaging, labeling, storage, installation and servicing of finished devices. Companies must also use change control to ensure changes to IT systems don’t create unintended risks.

But meeting FDA requirements around software validation and change control isn’t always straightforward, particularly if you don’t have in-house experts to guide the process.

With that in mind, let’s take a closer look at what’s required for initial validation, and how to use change control to maintain a validated Quality Management System (QMS).

Quality and safety, regardless of industry, are not as far off from one another as you’d think. In fact, most organizations share long term goals and don’t even know it. Sure, short term goals may not always be the same, but in the long term they very well can be. In fact, how many of your goals are to maintain a culture of integrity, compliance and consider the needs of customers and stakeholders?

With that said, an effective organization is likely to share both a safety and quality cultural mindset.

MD&M West is the world’s largest annual medtech expo and conference. We’re excited to announce that we’ll be attending this year’s conference in Anaheim, CA from February 7-9th, where we will showcase Verse in booth #2147.

With the turn of 2017 comes a lot of changes for the Life Science industry. ISO 13485:2016 and other regulatory updates mean that organizations must adapt to new ways of approaching quality management.

If you are like the many companies out there trying to keep up with the market and maintain a high level of compliance, turn to VERSE. We provide you with solutions for total quality management. Don't just follow—lead the charge in the industry and check out the VERSE total Quality, EHS and GMP Compliance Management Software, solutions.